Two parts of the safflower are primarily used: the flower itself and safflower seeds. There are two types of safflower oil with corresponding types of safflower varieties: those high in monounsaturated fatty acid (oleic) and those high in polyunsaturated fatty acid (linoleic). Currently, the seed varieties that produce oil high in oleic acid and very low in saturated fatty acids predominate in the United States market. High oleic safflower oil is lower in saturates and higher in monounsaturates than olive oil.

In the U.S. diet, safflower oil has been frequently substituted for oils with higher saturated fat content, as monounsaturated fat may have a beneficial effect on the risk of coronary heart disease.

Some clinical studies have shown that safflower oil supplementation may be helpful in patients with cystic fibrosis, Friedreich's ataxia, and neurotoxicity from lithium. However, more study is needed in these areas before a firm conclusion can be drawn.

In traditional Chinese medicine, safflower is used to invigorate the blood, dissipate stasis, amenorrhea (absence of menstruation), pain, and traumatic injuries. It is also used to "calm" a live fetus and abort a dead fetus, and is therefore used cautiously during pregnancy.

These uses have been tested in humans or animals. Safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.

GRADE *

Fatty acid intake is required for many physiological processes, including cellular maintenance skin repair, and production of prostaglandins. Safflower oil may improve fatty acid deficiency, especially oleic acid, linoleic acid and archadonic acid levels. Additional study is needed in this area before a strong conclusion can be made.

B

Safflower yellow injection may improve both western and traditional Chinese medicine symptoms for angina pectoris and coronary artery disease. More high-quality studies with safflower are needed to establish the effect of safflower yellow injection.

C

Limited available evidence suggests that safflower oil may increase oxidation of low-density lipoproteins (LDL) and lower thiobarbituric acid reactive substances (TBARS) when compared to fish oil. Additional study is needed in this area.

C

Safflower oil has lowered high blood pressure and coagulation in patients with chronic cor pulmonale, although there is limited available evidence in this area. Additional study is needed.

C

EH0202 is a traditional Japanese Kampo therapy containing safflower seed extract and is used for immunostimulation. EH0202 may decrease hepatitis C virus-RNA levels in patients with high viral titers. More studies with safflower alone are needed to define safflower's effect on hepatitis C.

C

Cystic fibrosis patients are frequently deficient in fatty acids due to reduced absorption of nutrients. Results from studies using safflower oil supplements are mixed. Additional study is needed.

C

Lipid (fat) abnormalities are commonly associated with diabetes, and complications of atherosclerotic disease are frequently associated with diabetes. Safflower oil may negatively affect glucose metabolism due to the extra intake of energy or fat, but these effects may be less pronounced than in fish oil.

C

Ingestion of certain lipids is known to affect various serum lipid levels. Preliminary evidence suggests that ingestion of safflower oil may reduce serum cholesterol levels. Additional study is needed.

Ingestion of certain lipids is known to affect various serum lipid levels. In the case of safflower oil, results are conflicting. More study is needed before a firm conclusion can be drawn.

C

Based on preliminary evidence, safflower oil may be involved in synthesis of prostaglandins, which are responsible for vascular regulation and inflammatory responses and may affect hypertension (high blood pressure). However, clinical studies have shown that safflower oil ingestion decreases or does not affect blood pressure. Due to the conflicting evidence, additional study is needed in this area.

C

There is currently insufficient available evidence to recommend for or against the use of safflower in the treatment of type II nephritic syndrome.

C

Safflower oil has been used in patients with protein-energy malnutrition to promote balance in their nutritional intake. Although the patients improved, the effect cannot be isolated to safflower oil intake because of the many other nutrients the patients were ingesting. Additional study is warranted in this area.

C

Infants require higher fat intake to support their rapid growth and brain development. Infant formula supplemented with safflower oil may increase the energy density of formula for very low-birth weight neonates. Although preliminary study is promising, more study is needed in this area to confirm these results.

C

Preliminary evidence looks promising for the use of safflower oil in the treatment of phrynoderma, a rough, dry skin generally associated with a vitamin A deficiency. Additional study is warranted in this area.

C

Parenteral nutrition requires a certain percentage of fats to provide full nutrition. Various sources of fats have been used, including safflower oil. Overall, clinical trials have shown safflower oil total parenteral nutrition (TPN) to be safe when used at the doses in the trials. However, more studies should be conducted to see if safflower oil is superior to other sources of TPN lipids.

C

Based on preliminary study, safflower oil may effectively remit the symptoms of neurotoxicity from lithium. However, more studies are needed to establish safflower's effect on lithium toxicity.

C

* Key to grades

A: Strong scientific evidence for this useB: Good scientific evidence for this useC: Unclear scientific evidence for this useD: Fair scientific evidence for this use (it may not work)F: Strong scientific evidence against this use (it likley does not work)

Tradition / Theory
The below uses are based on tradition, scientific theories, or limited research. They often have not been thoroughly tested in humans, and safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider. There may be other proposed uses that are not listed below.

Safflower oil has been used in varying doses in numerous clinical trials, and there is no proven effective dose. However, Liposyn® is possibly safe when used for up to 10 days to prevent essential fatty acid deficiency. When administered to patients undergoing operations, 10-20% safflower oil emulsions as 30-50% of total caloric intake were found to be safe as a major component of adult parenteral nutrition for up to 42 days, including cardiopulmonary bypass patients, and in children for up to two weeks.

For high blood pressure, 1-6 grams safflower oil daily for up to eight weeks has been used, as has 23 grams daily of linoleic acid or oleic acid (constituents of safflower seed oil) for four weeks. As an anti-coagulant (blood thinner), 60 milliliters daily of safflower oil for two weeks has been used. For atherosclerosis (lipid peroxidation), 15 grams of safflower oil daily has been used in postmenopausal women. Higher doses of safflower oil (102-132 milligrams per kilogram) daily have been studied for six weeks for cystic fibrosis.

Ethyl ester of safflower oil and linoleic acid have also been taken by mouth. Continued topical application of safflower oil (60-70% linoleic acid) for at least 21 days has been used for fatty acid deficiency.

Children (younger than 18 years):

Safflower oil has been used primarily in neonatal total parenteral nutrition. Brands studied include Liposyn® and Modified Liposyn®. 10 and 20% Liposyn® are equally safe and effective components of a parenteral nutrition program for children. Examples of other doses studied in clinical trials include: 1.0 grams per kilogram of safflower oil emulsion for four hours; 0.34-0.68 grams per kilogram of Liposyn® daily for five days in preterm infants; 0.68 grams per kilogram of Modified Liposyn® daily for five days in preterm infants; 23 grams of Liposyn® 20%, 25 grams of Modified Liposyn® 20%, or 50 grams of safflower oil-based lipid emulsion daily for up to seven days.

Safety
The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.

Allergies

Avoid in individuals with a known allergy or hypersensitivity to safflower. Safflower is a member the daisy family (Asteraceae/Compositae) and may cause allergic reactions in patients sensitive to daisies. Other members of this family include ragweed, chrysanthemums, marigolds, and many other plants. A case of contact dermatitis from safflower has been reported.

Side Effects and Warnings

In several clinical trials, 10-20% safflower oil emulsions were found to be safe and effective as a major component of adult parenteral nutrition. 10 and 20% Liposyn® are equally safe and effective components of a parenteral nutrition program for children. The most common adverse effects of safflower oil are cardiovascular, including increased serum lipids, and gastrointestinal, including diarrhea and loose stools.

Intravenous fat emulsion in newborns may cause hyperlipemia (high cholesterol) if serum triglycerides and free fatty acids are not monitored.

Belching, loose stools, nausea, vomiting, and diarrhea have been reported in patients taking safflower oil daily. Ingestion of high doses of safflower oil per day may decrease blood pressure. Use cautiously in patients with hypotension (low blood pressure), as safflower oil may cause a modest fall in blood pressure.

Other possible side effects of safflower supplementation that have been noted in clinical trials include cardiac arrhythmia (altered heart rate), diarrhea, angina (chest pain), death, increase in acne, development of diabetes, and development of necrotizing enterocolitis (intestinal illness in babies). These adverse effects are rare and it is unclear whether they can be solely attributed to safflower or whether another study drug caused these side effects. Use cautiously in patients with diabetes, as safflower oil may adversely affect glycemic control in type 2 diabetes patients.

Eosinophilia (increased number of white blood cells) developed in three newborn infants administered parenteral safflower oil emulsion for two weeks. Hypertriglyceridemia (elevated level of triglycerides, fatty acid compounds) has been reported during the intravenous infusion (injection) of a safflower oil-based fat emulsion. Elevation of serum triglyceride and liver enzyme concentrations occurred in some patients administered Liposyn®. Use safflower oil and parenteral safflower oil emulsions cautiously in patients with inadequate liver function, as they have been associated with elevation of liver enzyme concentrations.

Use parenteral safflower oil emulsions cautiously in newborns, as serum triglycerides and free fatty acids must be monitored to avoid the complications of iatrogenic hyperlipemia (high cholesterol) and intolerance. Use cautiously in patients with hypercoagulability, as safflower oil infusion may increase this condition.

Use cautiously in patients with skin pigmentation conditions, as kinobeon A, a rose-colored pigment found in safflower tissue, has demonstrated potent tyrosinase activity.

Pregnancy and Breastfeeding

Safflower flower is possibly unsafe in pregnant women, as Carthamus tinctorius may have stimulating action on the uterus. However, safflower oil is likely safe when used in food amounts in healthy patients. Soybean/safflower lipid-based emulsions are likely safe when administered to pregnant patients. Safflower oil is likely safe when used in breastfeeding women, although there is rapid transfer of dietary fatty acids into human milk.

In children with cystic fibrosis, ingestion of safflower oil, antacids, cimetidine and pancreatic capsules had greater increases in plasma linoleic acid levels.

Safflower may increase the risk of bleeding. Caution is advised in patients with bleeding disorders or taking drugs that may increase the risk of bleeding. Some examples include, aspirin, anticoagulants ("blood thinners") such as warfarin (Coumadin®) or heparin, anti-platelet drugs such as clopidogrel (Plavix®), and non-steroidal anti-inflammatory drugs (NSAIDS) such ibuprofen (Motrin®, Advil®) or naproxen (Naprosyn®, Aleve®). Dosing adjustments may be necessary.

Safflower may prohibit platelet aggregation and anticoagulation, and may promote microcirculation. Caution is advised when taking safflower with calcium channel blockers (verapamil). However, results are conflicting since safflower oil has also been documented to cause hypercoagulation. Check with a qualified healthcare professional before combining therapies.

Ingestion of safflower oil may decrease serum total cholesterol, HDL, LDL, apolipoprotein B, and malondialdehyde-LDL. Results are conflicting, although caution is advised nonetheless in patients taking cholesterol-lowering agents in combination with safflower oil.

Safflower oil may alter blood sugar levels; however, clinical relevance is unclear. Caution is advised when using medications that may lower blood sugar. Patients taking drugs for diabetes by mouth or insulin should be monitored closely by a qualified healthcare professional, including a pharmacist. Medication adjustments may be necessary.

Safflower oil may cause a modest fall in blood pressure and interact additively with hypotensive (blood pressure lowering) agents. However, several other clinical studies have shown no effect on blood pressure.

Safflower oil may have immunostimulation properties. Although clinical relevance is unknown, caution is advised when combining immunostimulating agents and safflower oil.

Although not well studied in humans, safflower oil may remit the symptoms of low-dose lithium neurotoxicity. This appears to be a positive interaction, although more study is needed to clarify this finding.

In children with cystic fibrosis, ingestion of safflower oil, antacids, cimetidine and pancreatic capsules had greater increases in plasma linoleic acid levels. In theory, safflower oil may interact with herbs or supplements with antacid effects.

Safflower may increase the risk of bleeding. Caution is advised in patients with bleeding disorders or taking herbs or supplements that are believed to increase the risk of bleeding.

Safflower oil may interact additively with fish oil to reduce C-reactive protein and interleukin-6. However, results are unclear. Caution is advised when combining fish oil with safflower oil.

Ingestion of safflower oil may decrease serum total cholesterol, HDL, LDL, apolipoprotein B, and malondialdehyde-LDL. Results are conflicting, although caution is advised nonetheless in patients taking cholesterol-lowering agents, such as red yeast rice, in combination with safflower oil.

Safflower oil may alter blood sugar levels. Caution is advised when using herbs or supplements that may lower blood sugar. Blood glucose levels may require monitoring, and doses may need adjustment.

Safflower oil may cause a modest fall in blood pressure and interact additively with hypotensive (blood pressure lowering) agents. However, several other clinical studies have shown no effect on blood pressure.

Safflower may interact when taken with safflower-containing products, such as Renal Disease Basic-prescription (RDBP) and EH0202 (pumpkin seed extract, safflower seed extract, Asian plantain seed extract, and Japanese honeysuckle flower extract). Safflower oil may also interact with calcium.

The information in this monograph is intended for informational purposes only, and is meant to help users better understand health concerns. Information is based on review of scientific research data, historical practice patterns, and clinical experience. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions.